BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 19015819 · Received April 1, 2024

    Report

    Report Number
    2025587-2024-02033
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    September 1, 2021
    Report Date
    April 1, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GARG J, SHAH S, SHAH K, TURAGAM MK, NATALE A, LAKKIREDDY D. HIS-BUNDLE PACING FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. PACING CLIN ELECTROPHYSIOL. 2021;44(10):1786-1789. DOI:10.1111/PACE.14351 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A SYSTEMATIC REVIEW OF HIS-BUNDLE PACING (HBP) FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THREE STUDIES WERE INCLUDED IN THE SYSTEMATIC REVIEW. MEDTRONIC COREVALVE (37.9%), EDWARDS SAPIEN (60.6%), AND ABBOTT PORTICO (1.5%) VALVE TYPES WERE IMPLANTED IN THE POOLED STUDY POPULATION OF 66 PATIENTS. ALL PATIENTS REQUIRED PERMANENT PACING AFTER TAVR AND UNDERWENT AN HBP IMPLANT PROCEDURE. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC TAVR PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589575 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention